510(k) K093373

LARYNGEAL SURFACE ELECTRODE by Spes Medica Srl — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2010
Date Received
October 29, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type